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- PMLiVE

EU launches black triangle drug monitoring scheme

New pharmacovigilance symbol will be used by all drugs needing additional monitoring

- PMLiVE

US shutdown threatens to disrupt FDA

Congress failure to agree budget cripples government functions

- PMLiVE

Lundbeck buoyed by Brintellix approval in US

FDA gives green light for to Cipralex/Lexapro successor in depression

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FDA gives green light to Roche for early Perjeta in breast cancer

Oncology drug can now be used before surgery in the US

Keith Webber leaves FDA for Perrigo

Switches regulatory agency for biopharma company

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EASD 2013: Sanofi justifies decision to withdraw US filing for Lyxumia

Takes issue with FDA's narrow risk-benefit focus

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Boehringer launches integrated Hispanic diabetes campaign

Creative development overseen Miami-based agency Republica

FDA takes ‘tailored’ approach to mobile app regulation

Issues final guidance on smartphone and tablet computer technology

- PMLiVE

Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

- PMLiVE

This month in 2010: How one woman helped prevent a health crisis in the US

The FDA's Frances Oldham Kelsey honoured for her work to prevent the use of thalidomide

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Breakthrough status for GSK/ Genmab’s Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

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FDA panel backs Perjeta in early breast cancer

Unanimous recommendation for use alongside Herceptin

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